Kornimate/medical-research-clean huggingface dataset:
left atrial appendage occlusion study iii extended follow up

Conditions: Heart Failure; Left Atrial Appendage Occlusion

Summary: laaos iii extension is a longer term follow-up of an international cohort study of patients who were enrolled in the left atrial appendage occlusion study (laaos iii) trial.

the association between atrial fibrillation and heart failure has been well established. although the causal relationship between the two clinical entities has not been fully elucidated, atrial fibrillation is believed to cause heart failure via several mechanisms: 1) increased heart rate resulting in shorter diastolic filling time and lower cardiac output; 2) reduced atrial contraction contribution to left ventricular filling, lowering cardiac output; and 3) tachycardia-induced cardiomyopathy from myocardial ischemia, myocardial energy depletion, and abnormal calcium regulation leading to left ventricular dilatation and reduced ejection fraction. these processes occur over time. it is also established that the left atrial appendage is a source of atrial natriuretic peptide, and it has been hypothesized that removal of the appendage might impair renal clearance of salt and water, increasing the risk of heart failure. a recent non-randomized study has supported this hypothesis. in laaos iii, we did not observe an increase in hospitalization for heart failure, either early after surgery or during the 3.8 years of follow-up. however, an adverse impact on heart failure may appear over a longer follow-up period. we need to ensure we examine this patient population for the long-term impact of left atrial appendage occlusion on heart failure hospitalization to ensure we fully appreciate the benefit-risk balance of this intervention. the extended follow-up of the laaos iii trial aims to assess whether, in patients with a history of atrial fibrillation undergoing cardiac surgery for another indication, concomitant left atrial appendage occlusion decreases the risk of death and stroke on top of usual care including anticoagulation without increasing re-hospitalization for heart failure at a mean follow-up of 8 years.

Eligibility criteria:
inclusion criteria: * participant was enrolled in the laaos iii trial * participant has provided written informed consent exclusion criteria: * participant did not undergo the index laaos iii cardiac surgery * participant underwent heart transplant
bandgrip vs traditional sutures tja

Conditions: Osteoarthritis

Summary: total joint arthroplasty (tja) has become one of the most performed elective procedures. while the results of this procedure are often consistent with high patient satisfaction and return-to-function, wound-related complications can contribute to high-cost "bundle busters". following surgery, wound drainage or other wound complications can lead to increased cost and decreased patient satisfaction. secure wound closure is an important step in preventing wound-related complications. the surgical incision should be closed in a manner that prevents the wound edges from separating which could lead to possible drainage and bacterial contamination of the incision. traditional incision closure following tja includes sutures. these sutures are then removed in the office. bandgrip is a wound closure device that can be used to approximate skin edges of wounds from surgical incisions and traumatic lacerations. it is a bandage-type patch with several small skin anchors that are used to hold the skin edges together. the clear microanchors are 0.029 inches in height and do not puncture through the dermis. there is no need for medical removal as the patient can remove the bandage.


Eligibility criteria:
inclusion criteria: 1. subject is male or female greater than 18 years of age 2. scheduled to undergo primary total knee or total hip replacement 3. able to read and comprehend informed consent form and comply with the follow-up evaluation schedule exclusion criteria: 1. prior surgical incision or scar in close proximity of the proposed incision (\<2 cm). 2. local skin conditions such as dermatitis, eczema, or psoriasis. 3. active or previous infection in the skin or the hip or knee to be operated. 4. inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical corticosteroid use 5. subject has a recent history of bleeding, coagulation and/or clotting disorders 6. subject has a known allergy to bandgrip material (polycarbonate)
chronic bronchiolitis or resistant asthma?

Conditions: Asthma

Summary: chronic bronchiolitis or resistant asthma? testing a way to diagnosis and treatment


Eligibility criteria:
inclusion criteria: * difficult asthma exclusion criteria: * patients with potential allergic bronchopulmonary aspergillosis i.e. with peripheral blood eosinophilia, sputum eosinophilia, or any sputum production and bronchiectasis * a history of smoking * significant occupational or environmental exposures * evidence on emphysema on chest high resolution computed tomography (hrct) scan
regular home use of dual-light photodynamic therapy on oral health in adolescents undergoing fixed orthodontic treatment

Conditions: Orthodontic Appliance Complication; Plaque, Dental; Gingival Inflammation

Summary: this study is designed to determine the efficacy of the lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. in addition, the device might have a photobiomodulation effect on periodontal tissues.

orthodontic treatment is one of the most common dental treatments in children and adolescents. the use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis. the lumoral is a ce-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. the device mechanism of action is antibacterial photodynamic therapy (apdt). the device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. the plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. forty (40) subjects undergoing fixed orthodontic treatment are randomized to the lumoral treatment group or the control group. all subjects shall receive polishing and oral hygiene instruction. all patients shall be assessed for the clinical measurements including visible plaque index (vpi), bleeding on probing (bop), and orthodontic plaque index (opi) at baseline and at 4 weeks and 12 weeks after baseline. in addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Eligibility criteria:
inclusion criteria: * age of 15-18 years old * starting fixed orthodontic treatment * good oral hygiene according to the dentist's assessment * absence of periodontal disease and lack of oral lesion * signed a written consent form, including information to caregivers. exclusion criteria: * any chronic diseases * medications that could influence the study (according to the dentists' assessment) * active caries or a supposed high risk of caries * gingivitis (bleeding on probing \>10%) * use of antiseptic mouthwashes * smoking * use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study * unable to cooperate with the protocol. * pregnancy or lactation
systematic imaging examination in odd

Conditions: Optic Disk Drusen

Summary: to evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (odd) in adolescents with mild visual impairment.

patients are evaluated through optometric examination, fundus photography, visual field examination, oct, us, and ffa.

Eligibility criteria:
inclusion criteria: 1. male or female. 2. age 14-28. 3. the results of visual acuity examination suggest mild visual impairment. 4. the results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested. exclusion criteria: 1. patients with amblyopia. 2. patients with neurological disease.
clinical trial to analyze the efficacy of a supplement extracted from persimmon on overweight / obesity.

Conditions: Supplementation; Obesity

Summary: randomized, controlled, double-blind clinical trial, with two parallel branches depending on the product consumed (experimental product and placebo product) and single-center, to measure the efficacy of a supplement extracted from persimmon on overweight and obesity grade i in subjects with bmi over 25.

the product to be consumed is a supplement extracted from the persimmon. participants will consume the product for 84 days. they will take one capsule before the two main meals. subjects will have to make 3 visits to the laboratory. in the initial visit it will be verified if the subject meets the criteria required by the study. subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). in the other two visits, the subjects will carry out the appropriate tests for taking of data colletion. these visits will be separated by 84 days of product consumption.

Eligibility criteria:
inclusion criteria: * subjects of both sexes aged 18-65 years. * subjects with a body mass index greater than 25 and less than 35. * volunteers able to understand the clinical study and willing to comply with the study procedures and the procedures and requirements of the study. exclusion criteria: * subjects undergoing treatment that may affect body weight. * subjects with acute diseases. * volunteers with a history or presence of chronic pulmonary disorders, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, urological, neurological, psychiatric, cardiovascular, or malignant tumor pathology or disease. * subjects who have undergone major surgery in the last 3 months. * subjects who quit smoking in the last 6 months or who intend to quit during the study. * subjects with allergies or eating disorders. * volunteers who are participating in another study that involves blood draws or dietary intervention. * pregnant or breastfeeding women.

Keywords: obesity overweight persimmon
wound drain after lumbar fusion surgery

Conditions: Lumbar Fusion

Summary: postoperative drain placement is often used following spine surgery. these drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression. the use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. the purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain


Eligibility criteria:
inclusion criteria: * age \> 18 * undergoing primary lumbar fusion or decompression and fusion for 1-2 levels * surgery indicated for lumbar degenerative disease exclusion criteria: * undergoing revision surgery * surgery indicated for infection * intraoperative dural tear * surgery requiring intraoperative transfusion
acute pediatric fracture analgesia study

Conditions: Fracture

Summary: a clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. we hypothesize that ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.

a clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. we hypothesize that ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. a random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. descriptive statistics will be used to analyze demographic data.

Eligibility criteria:
inclusion criteria: * children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting exclusion criteria: * a history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Keywords: fracture
efficacy assessment of chinese herbal medicine tangweian recipe treating participants with diabetic gastroenteropathy

Conditions: Diabetic Gastroenteropathy

Summary: this study is a randomized, positive drug parallel-controlled clinical trial in participants with diabetic gastroenteropathy. a total of 60 participants will be recruited for the study, all of whom are diagnosed as diabetes mellitus combined with gastroenteropathy. the subjects will be divided randomly into two groups and treated with either tangweian recipe+mosapride citrate tablets or mosapride citrate tablets for four weeks. the primary outcome will be the change in gastroparesis symptom severity, as measured by the american neurogastroenterology and motility society gastroparesis cardinal symptoms daily diary index-daily diary (anms gcsi-dd). and participants will be seen for a clinic evaluation at weeks 0 and 4, during which symptom scores, adverse events and treatment compliance will be assessed.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 70 years at the time of their consent; 2. those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer; 3. history of symptoms of mellitus for at least 5 years leading up to the screening visit and blood glucose stable within 1 month; 4. mean gastroparesis cardinal symptom index (gcsi) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (gebt); 5. tcm syndrome differentiation as spleen deficiency and stomach stagnation syndrome; 6. signed informed consent. exclusion criteria: 1. patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month; 2. patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with glp-1 class drugs; 3. have a history of or are suffering from severe gastrointestinal disease 4. gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year; 5. combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence; 6. women who are pregnant, preparing for pregnancy or breastfeeding; 7. patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies; 8. according to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

Keywords: diabetic gastroenteropathy
phase 1 to evaluate the safety and pharmacokinetic durg-drug interaction of yyc506-t and yyc506-a

Conditions: Dyslipidemias

Summary: to evaluate the safety and pharmacokinetics drug-drug interaction of yyc506-t and yyc506-a

phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of yyc506-t and yyc506-a. which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.

Eligibility criteria:
inclusion criteria: * over 19 ages healty men * over 50.0kg, 18.0kg/m2 ≤ bmi ≤30.0kg/m2 * men who dont have congenital disease and other cronic disease need to be cared etc. exclusion criteria: * men who have congenital liver disease (ast, alt, ck ≥ 2x uln) * men who have drunken or eatten something including carffeine within 24 hours before etc.
the effect of anticholinesterase drugs on sleep in alzheimer's disease patients

Conditions: Alzheimer Disease; Sleep Apnea, Obstructive

Summary: the purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep in alzheimer disease patients. sleep structure and respiratory parameters will be analyzed by polysomnography.

central acting cholinesterase inhibitors are the first primary pharmacological treatment approved for alzheimer disease, of which donepezil is the most frequently used. multicenter studies have found little toxicity, and its side effects (diarrhea, nausea, vomiting, nightmares, among others) are mild and transient. according to the literature, cholinergic active drugs may be expected to affect rem (rapid eye movement) sleep. another possible effect is related to respiratory parameters in patients with alzheimer disease and obstructive sleep apnea. in fact, cholinergic activity influences the upper airway opening via central and peripheral mechanisms. intervention: patients will be administered donepezil or placebo. the study has a randomized, double-blind placebo-controlled design. complete polysomnography with rem sleep eeg spectral analysis and adas-cog scoring will be performed at baseline and after 3 and 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease based on the probability criteria of the alzheimer's disease and related disorders association * rated 1 and 2 (mild to moderate level) on the brazilian version of the clinical dementia rating exclusion criteria: * other causes of dementia * other severe medical or psychiatric disease * clinical indication of psychoactive drugs other than experimental drug

Keywords: alzheimer polysomnography rem sleep donepezil sleep apnea oxygen saturation
minimally invasive sinus lift through the interradicular septum

Conditions: Bone Loss; Bone Loss, Age-related; Atrophy; Alveolar Process; Surgical Procedure, Unspecified

Summary: this study aims to describe a new approach for the reconstruction of the alveolar process in the sinus area. this minimally invasive approach will access the maxillary sinus through the alveolar process, elevating the sinus membrane in the area immediately above it. the regeneration may be achieved in the specific area required for dental implant placement, reducing the morbidity of the procedure.


Eligibility criteria:
inclusion criteria: * patient older than 18 years. * plaque index and bleeding index less than 30%. * invagination of the sinus cavity in the interradicular area of the upper first molar. * upper first molar not restorable and with height of the interradicular remnant less than 5 mm. exclusion criteria: * presence of systemic disease contraindicating the intervention. * pregnant women.

Keywords: maxillary sinus sinus lift xenograft
hepatitis a vaccine in patients with immunomodulating drugs

Conditions: Response to Hepatitis A Vaccine

Summary: hepatitis a vaccine is the most frequently used traveller's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travellers are scarce. the investigators assess the hepatitis a virus (hav) antibody response in patients with rheumatoid arthritis (ra) treated with tumor necrosis factor (tnf) - inhibitors and/or methotrexate (mtx).

methods: parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (visual analogue scale=vas, health assessment questionnaire disability index = haq, disease activity score =das-28, crp and total igg in plasma). hepatitis a vaccine (epaxal or havrix) were given at 0 and 6 months. hepatitis a virus (hav) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative hav igg, using the havab-igg architect system, and by the havab 2.0 assay on the axsym machine from abbott. the level of protective immunity to hav is defined as hav igg \> 10miu/ml.

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * tnf-alfa blocker and / or methotraxate in use as a medication against ra * a desire to get protected against hepatitis a * men and women age 18-65 years * written informed consent * women of childbearing potential must use effective contraception - exclusion criteria: * treatment with rituximab within 9 months before study start * known previous hepatitis a infection * previous vaccination against hepatitis a * allergy to eggs or formaldehyde * pregnancy or lactation * excessive use of alcohol * mental retardation * acute disease at the time of examination (fever \> 38 degrees) * volunteer works as an employee of the researchers * previous vaccination against hepatitis a * egg-, henprotein- or formaldehyde allergy * pregnancy or lactation * excessive use of alcohol * another vaccine given within a month * acute disease at the time of examination (fever \> 38 degrees) * not suitable for other reason in the investigator's opinion (other serious disease, i.e. aids/hiv-positive, cancer with ongoing cytostatic treatment)

Keywords: hepatitis a vaccine tnf-alfa inhibitory drugs rheumatoid arthritis methotrexate
immunomodulation analysis of radiation therapy in pediatric malignant brain tumors

Conditions: Brain Tumor, Pediatric

Summary: to investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.


Eligibility criteria:
inclusion criteria: * age from 3 to 18 * to be diagnosed with malignant brain tumors * to eligible for radiation therapy * karnofsky performance status ≥ 70 * no prior radiation exposure * informed consent signed for blood sample collection and used for research purpose exclusion criteria: * patients had received radiotherapy previously. * patients who had no histological diagnosis * patients who do not wish to participate * patients with infections